Evaluate the Use of Ganciclovir Gel 0.3% for the Treatment of Conjunctivitis Caused by Adenovirus

Conjunctivitis Clinical Trial

Official title:

"Prospective, Interventional, Randomized, Double-masked With the Use of Ganciclovir Gel 0.3% for Treatment of Conjunctivitis Caused by Adenovirus."

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01600365
• Other study ID #: ADA-GAN-02/10
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 22, 2011
• Last updated: May 15, 2012
• Start date: May 2012
• Est. completion date: June 2012

Study information

• Verified date: May 2012
• Source: Adapt Produtos Oftalmológicos Ltda.
• Contact: Rubens Belfort, PhD, MD
• Phone: 5511 55726443
• Email: rogeriomazon[@]adaptltda.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of conjunctivitis caused by adenovirus.

Description:

To evaluate the efficacy and tolerability of ganciclovir ophthalmic gel for the treatment of conjunctivitis comparing to placebo (ophthalmic gel). Visual acuity test and slit lamp examination (biomicroscopy) will be performed at each visit to assess the signs/symptoms and the regression of the disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with eye disease with a clinical diagnosis of adenovirus conjunctivitis.

• Patients of both gender aged over 18 years.

• Patients who are not pregnant or nursing.

• Patients able (legally and mentally) to understand and sign informed consent had been signed.

Exclusion Criteria:

• Patients who are in the presence of corticosteroids, either by topical ocular, periocular, intraocular or systemic, for less than 30 days of enrollment and who can not make a drug suspension.

• Patients with serious systemic diseases like AIDS, cancer, etc., which in the opinion of the investigator, may put the patient at risk.

• Patient with a single eye or vision in one eye.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenoviridae Infections
• Adenovirus.
• Conjunctivitis

Intervention

Drug:
• Ophthalmic gel (placebo)
Ophthalmic gel (placebo): applied in affected eye 4 times daily for 10 days
• Ganciclovir
Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Adapt Produtos Oftalmológicos Ltda.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to regression of the ocular symptomatology	Time to regression of ocular symptomatology compared to the baseline, as determined by clinical evaluation (biomicroscopy) performed on V1, V2 and V3, based on scale of absent, mild, moderate and severe.	10 days	No
Secondary	Development of sub-epithelial infiltrates	Development of sub-epithelial infiltrates,incidence for the study duration and severity at each follow-up visit (based on scale of absent, mild, moderate and severe)	10 days	No
Secondary	Degree of Bulbar conjunctival Injection	Degree of bulbar conjunctival injection at each follow-up visit, based on the scale of mild, moderate and severe	10 days	No
Secondary	Involvement of the second eye	Involvement of the second eye - incidence for the study duration and severity at each follow-up visit, as determined by the clinical evaluation (biomicroscopy)	10 days	No
Secondary	Patient Dairy - intensity of ocular pain	intensity of ocular pain selected by the patient on the "Patient Dairy" based on the visual analogue scale (VAS)on each follow-up visit (absent, mild, moderate, severe)	10 days	No